The purpose of the HARMONY study is to evaluate the safety and effectiveness of an investigational type 2 diabetes treatment that is taken once a week. The sections below provide further details about this study.
The investigational drug being evaluated in the HARMONY program is called albiglutide. This medication comes from a new class of drugs, which are similar to some currently approved diabetes drugs. However, albiglutide is designed to have a much longer-lasting effect.
Some diabetes medications must be injected multiple times a day. But, researchers are hopeful that one injection of albiglutide per week will be effective in controlling type 2 diabetes.
All study participants receiving treatment with albiglutide will be given an injector pen. The study staff will show you how to use this pen at home to administer your injections.
To pre-qualify for the HARMONY study, you must be:
Women who are pregnant or breast-feeding will not be allowed to participate in this study. There are additional criteria you must meet to enroll in this study.
Participants will receive study medication as well as study-related medical evaluations and tests at no cost.
Your total participation in the HARMONY program could last approximately 3 years, with up to 30 visits to the study clinic.
During the clinic visits, you will undergo a series of evaluations to monitor your safety and progress. These evaluations will include, but not be limited to:
In addition, you will be asked to use an at-home blood glucose meter (glucometer) to check your blood sugar levels on a regular basis. Study doctors will review the glucometer readings to monitor your safety and progress.
An FDA, EMEA and Asia/Pacific approved diabetes drug will be available at all times during this study, in the event that you experience hyperglycemia (high blood sugar). Your study doctor will provide you with more information.
As with any medical research study, there are some risks associated with participation. It is possible that you could experience a side effect caused by the study drug. The side effect could be one that is common and known, like nausea or loss of appetite. Or, you could experience a side effect that has never been seen before.
It is also possible that you could benefit by participating in this study. You may see improved control of your type 2 diabetes as well as weight loss, although this cannot be guaranteed. At the very least, the study staff will provide you with useful advice on how to help control your diabetes through diet and exercise, and you will receive expert medical attention and diagnostic tests at no cost.
If you have questions about the study medication or about this medical research in general, please contact the study staff. They are available to answer all of your questions.